...patients with late-stage mutant-IDH2 relapsed or refractory acute myeloid leukemia treated with enasidenib...a trend for improved OS with ENA was detected in pts with IDH2-R172 mutations....ENA improved survival outcomes for pts with IDH2-R172 mutations, with median OS and 1-year survival rate approximately double those in the CCR arm.

In mIDH2-R172 pts, median OS was ~2-fold longer with ENA (n=43) vs CCR (n=45): 14.6 vs 7.8 mo (HR 0.59; P=0.039)....ENA provided meaningful improvements in 1-yr survival, EFS, and morphologic response vs CCR, and ENA prolonged OS for pts preselected to lower-intensity Tx and pts with mIDH2-R172 AML.

The ORR for patients with IDH2-R140 mutations was 35.4% (95% CI, 27.2%-44.2%) and for those with IDH2-R172 mutations, ORR was 53.3% (95% CI, 37.9%-68.3%). Rates of complete remission were 17.7% (95% CI, 11.6%-25.4%) in patients with IDH2-R140 mutations and 24.4% (95% CI, 12.9%-39.5%) for patients with IDH2-R172 mutations....In conclusion, data from this study showed that single-agent enasidenib was well tolerated, induced hematologic responses, and was associated with a median survival of more than 9 months in patients with relapsed or refractory mutant-IDH2 AML.